Background: This study aims to investigate the impact of test conditions on the results of the compression testing of microneedle arrays (MNAs). Methods: Uniaxial compression tests were conducted on polyglycolic acid-fabricated biodegradable MNAs. Load–displacement curves were obtained for varying conditions, including the number of microneedles (MNs) compressed simultaneously, compression speeds, and compression angles. Subsequently, the buckling load and stiffness were calculated, and the MN deformation during compression was observed. Results: The buckling load and stiffness per MN decreased significantly with a simultaneous increase in compressed MNs. The mean buckling load and stiffness of 52 MNs in single-needle compression tests were 0.211 ± 0.008 N and 13.9 ± 1.3 N/mm, respectively, with no variation among the three MNAs. However, a significant difference in buckling load and stiffness was observed among the MNs within the MNAs. Additionally, buckling loads and stiffnesses were significantly lower in certain MNs at the same location in different MNAs. Buckling load and stiffness decreased significantly during inclined compression compared to during vertical compression. While the tests evaluate the mechanical properties of MNAs, test results may vary depending on test conditions. Conclusions: Compression testing of the individual MNs comprising an MNA helps evaluate the mechanical properties of MNs and ensure the quality of MNAs.

Fontan procedure is one of the common surgical treatments of congenital heart diseases. Patients with Fontan circulation have single ventricle in the systemic circulation with the total cavopulmonary connection. We have been developing a pulmonary circulatory assist device using shape memory alloy fibers for Fontan circulation with total cavopulmonary connection. It consisted of the shape memory alloy fibers, the diameter of which are 100 μm. The fibers could wrap the ePTFE conduit for Fontan TCPC connection from the outside. We designed the sequential motion control system for sophisticated pulmonary hemodynamics by the pulsatile flow generation. In order to achieve pulsatile flow assistance in pulmonary arterial system, we fabricated a mechanical structure by sequential contraction of shape memory alloy fibers. Then, we developed a sequential contraction controller for the assist system, which could reproduce the wall contractile velocity at 6.0 to 20.0 cm/sec. We examined hemodynamic characteristic of its function using a mock circulatory system, which consisted of two overflow tanks representing venous and pulmonary arterial pressures in Fontan circulation. As a result, the pulmonary circulation assist device with sequential contraction could achieve effective promotion of the pulsatility in pulmonary arterial flow.

Diastolic counter-pulsation has been used to provide circulatory augmentation for short term cardiac support. The success of intra-aortic balloon pump (IABP) therapy has generated interest in long term counter-pulsation strategies to treat heart failure patients. The authors have been developing a totally implantable extra aortic pulsation device for the circulatory support of heart failure patients, using 150μm Ni-Ti anisotropic shape memory alloy (SMA) fibers. These fibers contract by Joule heating with an electric current supply. The special features of our design are as follow: non blood contacting, extra aortic pulsation function synchronizing with the native heart, a wrapping mechanical structure for the aorta in order to achieve its assistance as the aortomyoplsty and the extra aortic balloon pump. The device consisted of rubber silicone wall plates, serially connected for radial contraction. We examined the contractile function of the device, as well as it controlling methods; the phase delay parameter and the pulse width modulation, in a systemic mock circulatory system, with a pneumatically driven silicone left ventricle model, arterial rubber tubing, a peripheral resistance unit, and a venous reservoir. The device was secured around the aortic tubing with a counter-pulsation mode of 1-4 against the heartbeat. Pressure and flow waveforms were measured at the aortic outflow, as well as its driving condition of the contraction phase width and the phase delay. The device achieved its variable phase control for co-pulsation or counter-pulsation modes by changing the phase delay of the SMA fibers. Peak diastolic pressure significantly augmented, mean flow increased (p<;0.05) according to the pulse width modulation. Therefore the newly developed extra aortic counter-pulsation device using SMA fibers, through it controlling methods indicated its promising alternative extra aortic approach for non-blood contacting cardiovascular circulatory support.